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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06849258




Registration number
NCT06849258
Ethics application status
Date submitted
17/02/2025
Date registered
27/02/2025

Titles & IDs
Public title
A Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men with Benign Prostatic Hyperplasia Symptoms
Scientific title
A Prospective, Multicenter, Double Blind, Randomized, Clinical Study to Evaluate the Safety and Efficacy of the FloStent in Men Suffering from Benign Prostatic Hyperplasia Symptoms
Secondary ID [1] 0 0
C0002 Rev. 07
Universal Trial Number (UTN)
Trial acronym
RAPID-III
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Benign Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - FloStent
Treatment: Devices - Sham (Control)

Experimental: Treatment - FloStent - Flexible cystoscopy procedure with FloStent implant deployed

Sham comparator: Sham Control - Flexible cystoscopy procedure without FloStent implant deployed


Treatment: Devices: FloStent
Flexible cystoscopy to deploy medical device used to treat BPH

Treatment: Devices: Sham (Control)
Flexible Cystoscopy without deployment of medical device used to treat BPH
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in International Prostate Symptom Score (IPSS)
Timepoint [1] 0 0
12 months
Secondary outcome [1] 0 0
Percent responders to IPSS
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Percent responders to IPSS
Timepoint [2] 0 0
6 months
Secondary outcome [3] 0 0
Percent responders to IPSS
Timepoint [3] 0 0
12 months

Eligibility
Key inclusion criteria
* Male subjects > 45 years of age who have symptomatic BPH
* International Prostate Symptom Score (IPSS) score >13
* Peak urinary flow rate (Qmax): >5 mL/sec and <13 mL/sec with minimum voided volume of >125 mL
* Post-void residual (PVR) <250 mL
* Prostate volume 25 to 80 mL
* Prostatic urethral length 20-50 mm
* Able to complete the study protocol and visits
Minimum age
45 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Presence of an artificial urinary sphincter or stent(s) in the urethra or prostate
* Prior minimally invasive intervention or surgical intervention of the prostate or urethra
* PSA >10 ng/mL
* Bladder cancer or bladder stones
* Active urinary tract infection (UTI)
* Uncontrolled diabetes
* Part of a vulnerable population (cognitively challenged or are incarcerated)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/02/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2032
Actual
Sample size
Target
215
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
South Coast Urology - Wollongong
Recruitment postcode(s) [1] 0 0
2500 - Wollongong
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Michigan
Country [7] 0 0
United States of America
State/province [7] 0 0
Nevada
Country [8] 0 0
United States of America
State/province [8] 0 0
New York
Country [9] 0 0
United States of America
State/province [9] 0 0
North Carolina
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Rivermark Medical
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Study Director, MD
Address 0 0
Rivermark Medical, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Manager Study Director, MD
Address 0 0
Country 0 0
Phone 0 0
773-307-9665
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06849258